Specification of Drug Substances and Products

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them.

"...a valuable addition to a pharmaceutical scientists’ library….relevant and of interest to various “stake-holders” in the drug development arena, including chemists, analysts, and programme managers. I can recommend it." --Organic Process Research & Development Journal, Sep-14 "Its main role is to explain how to meet the most recent International Conference on Harmonization guidelines for drug development. The book is organized to offer a critical and comprehensive account of the approaches used to identify the key determinants of quality production that affect the safety, effectiveness, and marketability of a drug." --ProtoView.com, April 2014

Dr Riley is President, Riley and Rabel Consulting Services, Inc. He received a bachelor’s degree in pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, England. He was a post-doctoral fellow at the University of Kansas in the Department of Pharmaceutical Chemistry (1981-1982) before joining the faculty of the Department of Pharmaceutics at the University of Florida. He returned to the University of Kansas as faculty member in 1986 where he remained until 1994. He was Vice President and Head of Analytical R&D at Dupont Pharmaceuticals (previously Dupont Merck) from 1994 to 2001. He joined ALZA 2001, a subsidiary of Johnson & Johnson, where he had positions of increasing responsibility up to Vice President and West Coast Site Head ChemPharm Development. He left ALZA in May 2007 to form Riley and Rabel Consulting Services, Inc., which provides consulting services to the Pharmaceutical and Biotechnology Industries, specializing in Analytical and Pharmaceutical Development, CMC Strategy, Organizational and Managerial Effectiveness and Patent Litigation. He has co-authored more than 140 book chapters and papers in peer-reviewed journals, as well as five books. He was awarded the Conference Science Award of the Royal Pharmaceutical Society of Great Britain and the Jubilee Medal of the Chromatographic Society. He was elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and served as the chair of the Analysis and Pharmaceutical Quality Section of AAPS and a Member of the AAPS Executive Committee. Dr. Riley has served as member and chair of the PhRMA Analytical Technical Committee (ATC), as well as a member and chair of the PhRMA Technical Leadership Committee (TLC). Dr. Riley represented PhRMA on the ICH Expert Working Group on Impurities in Drug Substances (Q3A) and Drug Products (Q3B) and was Chair of the PhRMA Working Group on Genotoxic Impurities. Former Director of Business Development at Acceleration Laboratory Services, Incorporated. He has previously held scientific and senior management positions at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel, Quintiles, Eli Lilly, Beckloff Associates, and PPD. He currently serves on a Small Molecule USP Expert Committee.